Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01309945
First received: February 15, 2011
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued duloxetine in the treatment of patients with treatment resistant depression (TRD).
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Duloxetine Drug: Placebo matching with BMS-820836 Drug: BMS-820836 Drug: Placebo matching with Duloxetine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-blind, Active-Controlled Study of the Efficacy and Safety of Flexibly-Dosed BMS-820836 in Patients With Treatment Resistant Major Depression |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Change in Montgomery Asberg Depression Rating Scale (MADRS) total score [ Time Frame: End of phase B and End of phase C ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in Sheehan Disability Scale (SDS) Total score [ Time Frame: End of Phase B and End of Phase C ] [ Designated as safety issue: No ]
- Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score [ Time Frame: End of Phase B and End of Phase C ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 406 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Arm 1: Duloxetine 30mg |
Drug: Duloxetine
Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks
Other Name: Cymbalta
|
| Placebo Comparator: Arm 2: BMS-820836 placebo |
Drug: Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks
|
| Experimental: Arm 3: BMS-820836 0.5-2.0 mg/day |
Drug: BMS-820836
Tablet, Oral, 0.5-2.0 mg, once daily (QD), 6 weeks
|
| Active Comparator: Arm 4: Duloxetine 30mg |
Drug: Duloxetine
Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks
Other Name: Cymbalta
|
| Placebo Comparator: Arm 5: Duloxetine placebo |
Drug: Placebo matching with Duloxetine
Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use.
- Patients with a diagnosis of Major Depressive Disorder, currently experiencing a Major Depressive Episode, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition Text Revision(DSM IV TR) criteria. The current depressive episode must be > 8 weeks in duration and < 3 years duration.
- In the current Major Depressive Disorder (MDD) episode, patients should report a history of inadequate response to 1 - 3 adequate trials of antidepressant treatment.
- Patients must have a 17-item Hamilton Depression Rating Scale (HAM-D17) total score =>18 at Screening.
Exclusion Criteria:
- Patients who report an inadequate response (less than 50% reduction in depressive symptom severity) to more than three adequate trials of antidepressant treatments during the current depressive episode.
- Patients who have failed duloxetine at an adequate dose and for an adequate duration in their current episode unless in the judgment of the investigator, the patient could benefit from the treatment with this medication.
- Patients whose only inadequate response to an antidepressant in the current Major Depressive Episode (MDE) is to an Serotonin norepinephrine reuptake inhibitors (SNRI) (duloxetine, venlafaxine, desvenlafaxine or milnacipran).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309945
Show 87 Study Locations
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Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01309945 History of Changes |
| Other Study ID Numbers: | CN162-006, 2010-022841-93 |
| Study First Received: | February 15, 2011 |
| Last Updated: | January 23, 2013 |
| Health Authority: | Sweden: Medical Products Agency Finland: Finnish Medicines Agency Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) South Africa: Medicines Control Council South Africa: Department of Health United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013